The change in the total Severe Impairment Battery (SIB) score at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

All statistical tests will be conducted at the 0.05 level of significance (two-tailed). A positive outcome will be declared if for the primary efficacy endpoint as measured by the Severe Impairment Battery (SIB), the change from Baseline to Week 24 in the total SIB score last observation carried forward (LOCF) demonstrates superiority for donepezil 10 mg, compared with placebo.

An ANCOVA with embedded Cochran-Mantel-Haenszel (CMH) test will be used with the CIBIC+ and center in the model. Overall change from Baseline in scores at Week 24 (LOCF) will be analyzed with the same model as the SIB.

Subjects with a known history of disorders that affect cognition or the ability to assess cognition, but are distinguishable from AD

Evidence of focal disease to account for dementia on any cranial image MRI or CT.

Subjects with dementia complicated by other organic disease or AD with delirium according to DSM-IV criteria

Subjects who cannot swallow or who have difficulty swallowing whole tablets, as tablets should not be broken or crushed

Illiteracy prior to AD

Subjects who are unwilling or unable to fulfill the requirements of the study

Treatment with another cholinesterase inhibitor and/or memantine in the 3 months prior to Screening

Subjects with a poor response (tolerability) to prior exposure to donepezil

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404169